New Study Shows That Telmisartan Has Greater Renoprotective Potential Than Losartan in Hypertensive Patients with Type 2 Diabetes

2007-06-18 09:23 714

MILAN, Italy, June 18 /Xinhua-PRNewswire/ -- Today AMADEO, one of the first studies to compare the protective potential of two angiotensin receptor blockers in hypertensive patients with diabetic nephropathy, was presented at the European Society of Hypertension, Milan. The results from this study show that telmisartan reduces proteinuria to a significantly greater extent than losartan.(1)

Commenting on the results, Prof. Ellen Burgess, Foothills Hospital in Calgary, Canada said "The AMADEO results are encouraging for an increasing number of patients with type 2 diabetes because they suggest that telmisartan could improve renoprotection. It is particularly interesting that the observed effect was seen despite the study being controlled for blood pressure." She continued, "telmisartan has already shown superior blood pressure lowering compared to losartan and, in AMADEO, patients were allowed to take other medication, if needed, to ensure similar blood pressure in both treatment groups. This suggests that the protective benefits seen with telmisartan here are an additional attribute beyond its established blood pressure lowering effects."

Diabetic nephropathy is a kidney disease that occurs in approximately one third of patients with diabetes mellitus(2). These study results could, therefore, have a positive impact on millions of type 2 diabetes patients as well as healthcare systems worldwide. The prevalence of diabetes is projected to increase at an alarming rate from 171 million in 2000 to 366 million by 2030(3), with the upsurge in obesity closely linked to increased type 2 diabetes. Over time, diabetic nephropathy can lead to end-stage renal disease, a serious condition that needs dialysis and increased medical care and resources. End-stage renal disease has tripled in prevalence over the past two decades(4) and has huge associated healthcare costs, predicted to be US$28billion by 2010 in the US alone(5).

AMADEO, a randomized, double-blind, forced-titration, parallel-group, multicentre study, included 860 hypertensive patients (>130/80mmHg) with type 2 diabetes and overt nephropathy from 124 centres in 10 countries. Patients were randomized to receive treatment with either telmisartan 80mg or losartan 100mg. To ensure blood pressure control in the two patient groups other non- ARB treatments (hydrochlorothiazide or calcium channel blocker) were added, if needed.

After one year's treatment, telmisartan was significantly more effective than losartan in reducing the amount of protein excreted in the urine. The primary end point of the study was reduced by 29% with telmisartan vs. 20% with losartan; p=0.0284(1).

Telmisartan was superior to losartan on the primary endpoint, a change from baseline after 12 months (log transformed Urinary Protein creatinine ratio) of 0.71 (95% CI; 0.66, 0.77) vs. 0.80 (95% CI; 0.74,0.87) for losartan; p=0.0284.(1)

No significant difference in blood pressure control or number of adverse events was observed between the two treatments groups(1).

Proteinuria (high levels of protein in the urine) is a very important signal for disease severity in diabetic nephropathy and is also considered a relevant cardiovascular risk factor. Renal outcomes trials have shown that reductions of >30% at six months are strongly linked to slowed progression to end-stage kidney disease and reduced cardiovascular events.(6)

AMADEO successfully concludes the series of PROTECTION studies which are part of an extensive ongoing trial programme, including clinical and observational studies, investigating the outstanding effects of telmisartan compared with other treatments for hypertension, including other available ARBs. The trials established the effects of telmisartan in providing powerful blood pressure reductions from morning to morning as well as organ-protective effects.

Telmisartan has a longer duration of action than all other members of the ARB class; it takes approximately 24 hours for half the dose of telmisartan to be eliminated from the body compared to five to 15 hours for other ARBs.(7,8) Telmisartan is 99.5% bound to serum protein and is excreted almost entirely via non-renal pathways.

Clinical trials have shown that telmisartan provides powerful and consistent blood pressure reduction over a full 24 hour period.(7-10)

About Telmisartan (Micardis(R)/Kinzal(R)/Pritor(R))

Telmisartan is a member of the angiotensin II receptor blocker (ARB) class and is being investigated in the most ambitious and far-reaching research programme ever conducted with an ARB. In the clinical trial programmes PROTECTION, ONTARGET and PRoFESS, over 58,000 patients have been enrolled to investigate the cardiovascular protective effects of Telmisartan.

Telmisartan was discovered and developed by Boehringer Ingelheim. Under the trademarks Micardis(R) and MicardisPlus(R) (combination with HCTZ) the company markets Telmisartan in 84 countries around the world, including the USA, Japan and European countries. Telmisartan is marketed in cooperation with Astellas Pharma Inc. in Japan, Bayer HealthCare in Europe and GlaxoSmithKline in selected markets. Bayer HealthCare promotes Telmisartan under the brand names Kinzalmono(R), Kinzalkomb(R) (combination with HCTZ), and Pritor(R) and PritorPlus(R) in markets across Europe. Pritor(R) and PritorPlus(R) is also marketed by GlaxoSmithKline in selected markets.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and almost 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

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1. Burgess E et al. Efficacy of telmisartan compared with losartan in reducing proteinuria in hypertensive type 2 diabetic patients with overt nephropathy. Presented at the Annual Meeting of the European Society of Hypertension. June 2007, Milan, Italy.

2. Hossain P et al. Obesity and Diabetes in the Developing World -- a Growing Challenge. NEJM 2007; 356(3):213-215.

3. Wild S et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004; 27:1047-53.

4. US Renal Data System. USRDS 2006 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. Available at: Accessed 06-2007.

5. Yue JL et al. Forecast of the number of patients with end-stage renal disease in the United States to the year 2010. J Am Soc Nephrol. 2001; 12:2735-8.

6. Bakris G et al. Comparative long term effects of two AT1 receptor blockers on proteinuria in patients with type-2 diabetes and overt nephropathy and hypertension: results of the AMADEO trial. Presented at the Annual Meeting of the American Society of Hypertension. May 2007, Chicago, USA

7. Burnier M, Brunner HR. Lancet 2000;355:637-45.

8. Brunner HR. J Hum Hypertens 2002;16(suppl 2):S13-S16.

9. Neutel JM, Smith HG. J Clin Hypertens 2003;5(1):58-63.

10. Millar-Craig MW et al. Lancet 1978;1:795-97.

Source: Boehringer Ingelheim